For drugs that cannot be marketed as ready-to-use injectables due to their instability in an aqueous environment, Suspension Powders for Injection (PIs) are a popular parenteral dosage form. PIs are sold as dry powders that must be reconstituted with the appropriate vehicle just before administration. The final form after reconstitution can be either a solution or a suspension. For instance, powdered vaccines are mixed with sterile saline just prior to administration. The following is a guide on what you need to know about sizing of injectable drug powder in sterile production.
PIs are uncomplicated in regards to formulation and process development to size sterile, freeze dried (lyophilized), pharmaceutical powders. The sterile powders are put in sterile vials for use as an injectable dosage form. The powder in the vials is stable for an extended period of time as it is freeze dried, sealed under vacuum, and sterile. When it is time to use the drug, a solvent such as sterile water is added by syringe to the vial and the vial is shaken to dissolve the powder. The mixed suspension is withdrawn from the vial by syringe and injected into the patient's blood stream.
It is essential that the powder in the vial be a consistent particle size and free of clumps in order to promote dissolution or suspension and to provide the needed maximum particle size to suit the size of the needle and application in which it is used. In order to ensure maximum particle size, a size reduction step is needed between freeze drying and the actual filling of the vials. As well, the nature of administration of the product requires that sterile conditions be maintained throughout the manufacturing process.
Today, technology has been developed for a suitable size reduction mill for this very specialized application. The addition of buffering agents such as sodium carbonate to control the pH or solubilizers such as L-arginine is the most common method to improve the solubility of a drug in PI dosage forms.
An innovative technological solution known as the Comil is polished to an ultra sanitary finish and can be sterilized by autoclave, steam in place, or with hydrogen peroxide gas. The Z top-driven unit is equipped with a unique centrifugal seal to prevent cross contamination between batches which can occur from some standard mills. The spindle assembly can be equipped with sanitary mechanical seals if running under high temperatures is required and it can be offered as a certified pressure vessel should steam in place pressures be warranted. The removable head can easily be disassembled for autoclave sterilization.
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